- STERIS (St. Paul, MN)
- Senior Manager, Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs St Paul, MN, US, 55102 Description: At STERIS, we ... around the globe. Position Summary The mission of the Regulatory Affairs group is to implement effective...address registration related issues. Act as person responsible for regulatory compliance as assigned by upper management.… more
- Abbott (Plymouth, MN)
- …2-5 years of experience in regulatory preferred but may consider quality assurance, research and + development/support, scientific affairs , operations, or ... and get on with their lives. **The Opportunity** The Regulatory Affairs Manager will work out of...Review and approve advertising and promotional items to ensure regulatory compliance . Ensure external communications meet regulations.… more
- Philips (Plymouth, MN)
- …and recommending changes for design control processes and manufacturing procedures to maintain quality and regulatory compliance ._ + _Providing guidance on ... **Senior Regulatory Affairs Manager (US Hub based...to team members is important._ + _Driving improvement in regulatory aspects of the Quality Management System… more
- Medtronic (Minneapolis, MN)
- Position Description: Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing ... Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance . Work on PMA (Pre-Market Approval) or 510(k)… more
- Medtronic (Plymouth, MN)
- … regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high- quality execution of ... Senior Regulatory Affairs Specialist - Peripheral Vascular...changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance . Review and approve RAC's, RAN's,… more
- Philips (Plymouth, MN)
- …System. Reviews and recommends changes for design process and manufacturing procedures to maintain quality and regulatory compliance . + Key role in external ... Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance . Keeps abreast of current regulatory procedures… more
- Teleflex (Maple Grove, MN)
- …for information. * Apply understanding of the quality systems to ensure regulatory requirement compliance and to perform job activities and projects. * Bring ... Sr. Regulatory Affairs Specialist **Date:** Apr 13,...advertising, instructions for use, and promotional) verbiage to ensure regulatory compliance and substantiated claims. * Interface… more
- Philips (Plymouth, MN)
- …Management, you will work in a dynamic organization that includes Quality , Regulatory Affairs , Medical Office, Compliance , Quality Services, and ... Philips' Medical products are safe, reliable and compliant with internal/external quality / regulatory standards. **Your role:** + The Senior Program Manager… more
- Stryker (Bloomington, MN)
- …to apply? Here are 10 reasons to join our Regulatory Affairs / Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- ... a timely manner. We are currently seeking a **Manager, Regulatory Affairs ** to join our **Upper Extremities**...to bring medical devices to market and ensure ongoing compliance while managing a regulatory team. +… more
- Abbott (St. Paul, MN)
- …the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Project Manager** to join our team on-site in our St. ... Our business purpose is to restore health and improve quality of life through the design and provision of...individual contributor leads project submissions for FDA and EU regulatory approvals and acts independently to identify and resolve… more
- State of Minnesota (Brooklyn Park, MN)
- **Working Title: Director of Tribal Affairs ** **Job Class: State Program Administrator, Manager** **Agency: Pollution Control Agency** + **Job ID** : 76330 + ... / Pollution Control-Managerial + **Division/Unit** : Director of Tribal Affairs / COMMISSIONER'S OFFICE + **Work Shift/Work Hours** :...essential services, and working to improve the well-being and quality of life for all Minnesotans. The State of… more
- Post Holdings Inc. (Hopkins, MN)
- …including customer service, quality assurance, R&D and operations. Primarily support regulatory compliance with the FDA and USDA FSIS. The position will ... report to the Director of Regulatory Affairs and Customer Compliance ....two years' experience in USDA/FDA domestic regulatory compliance . Preferably, working as a Food Safety Quality… more
- Cardinal Health (St. Paul, MN)
- …Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Medical Affairs + Product Lifecycle Management + Initial ... capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical… more
- Sumitomo Pharma (St. Paul, MN)
- …contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with regulatory ... individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of...compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the… more
- Merck (St. Paul, MN)
- …and proactively and result in outcomes that demonstrate the Company's commitment to regulatory compliance . + Ensures that a cross-functional team (eg Quality ... colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is… more
- Abbott (Maple Grove, MN)
- …regulatory authority inspection or audit, or corporate or divisional regulatory compliance audit. + May support other clinical quality tasks as requested ... . This new team member will be responsible for supporting Global Clinical Affairs personnel globally in ensuring compliance with medical device and GCP… more
- Abbott (Maple Grove, MN)
- …to detail. + 5-7+ years of experience in clinical research, clinical affairs , regulatory affairs , or quality systems, in the medical device or ... device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking… more
- Takeda Pharmaceuticals (St. Paul, MN)
- …You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met ... and/or related experience. + Understanding of scientific principles and regulatory / quality systems relevant to drug development. +...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more
- J&J Family of Companies (St. Paul, MN)
- …and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements. * Works with SM to ensure CAPA ... for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries....coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with… more
- Abbott (St. Paul, MN)
- …engineering, safety management quality , environmental science, scientific discipline or regulatory affairs + Technical experience in chemical, mechanical or ... initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory ...+ Drives functional performance that meets required standards and regulatory compliance **WHAT WE OFFER** + At… more